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OpenTrials
Completed

NCT Number: NCT06242769

Clinical Research Study to Evaluate the Stain Removal Efficacy

The objective of this clinical research study is to evaluate the stain removal efficacy of a toothpaste containing stannous fluoride as compared to negative control toothpaste in adults.

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Key information

Conditions

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dental Research Associates, Inc.

San Juan, 00927, Puerto Rico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Informed Consent Form
  • Good general health
  • Male and female subjects, aged 21-70, inclusive
  • Present 12 scoreable natural anterior teeth
  • A minimum mean Composite Lobene Index score of 1 or greater
  • Available for the duration of the study
  • Clinical evidence of a tendency to form extrinsic stain on anterior teeth

Exclusion criteria

  • Presence of orthodontic bands
  • Presence of partial removable dentures
  • Tumor(s) of the soft or hard tissues of the oral cavity
  • Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)
  • Five or more carious lesions requiring immediate restorative treatment
  • Use of antibiotics or stain inducing medications any time during the one month prior to entry into the study
  • Participation in any other clinical study or test panel within the one month prior to entry into the study
  • Self-reported pregnancy and/or women who are breast feeding
  • Dental prophylaxis received in the past four weeks prior to baseline examinations
  • History of allergies to oral care/personal care consumer products or their ingredients, including allergies to hydrogen peroxide
  • On any prescription medicines that might interfere with the study outcome
  • History of alcohol and/or drug abuse
  • Exposed to a tooth whitening procedure during the last 3 months

Treatment and study plan

Stannous Fluoride Toothpaste (SnF)

Drug

test

Colgate Fluoride Toothpaste (CDC)

Drug

negative control

Primary outcomes

  1. Composite Lobene Stain Index

    Time frame: measurement at baseline, 3 week & 6 week

    subjects will be evaluated for tooth stain by the dental examiner

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

Clinical Research Study to Evaluate the Stain Removal Efficacy of a Toothpaste Containing Stannous Fluoride as Compared to Negative Control Toothpaste.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2024
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.